Product Code: SGZ
FDA class 2
21 CFR 878.4635
Ultraviolet Lamp Products
General, Plastic Surgery
510(k)s
1
FEI Numbers
2
Registration Numbers
2
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- SGZ
- Device Class
- FDA class 2
- Regulation Number
- 878.4635
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
An ultraviolet lamp product intended to stimulate the production of Vitamin D
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252960 | SOLIUS PRO UVB Light Panel | Jan 16, 2026 | Substantially Equivalent | Solius Labs, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.